Business
Recursion’s Phase 2 Trial for the Treatment of Cerebral Cavernous Malformation has Fully Enrolled
Recursion's small molecule is the first therapeutic candidate to be advanced to an industry-sponsored Phase 2 clinical trial for cerebral cavernous
About this update from Recursion Pharmaceuticals, Inc.
[{"type":"text","content":"Recursion's small molecule is the first therapeutic candidate to be advanced to an industry-sponsored Phase 2 clinical trial for cerebral cavernous malformation (CCM). CCM is a devastating neurovascular disease with approximately 360,000 symptomatic patients in the United States and EU5.\nSALT LAKE CITY, June 13, 2023 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced the full enrollment of its Phase 2 SYCAMORE clinical trial evaluating REC-994, a potentially first-in-class, orally bioavailable small molecule for the treatment of CCM. \"We are encouraged by the full enrollment of our Phase 2 trial ahead of schedule,\" said Recursion’s Chief Medical Officer, David Mauro, M.D, Ph.D. \"We are pleased with the continued enthusiasm and support of the patient community and to see patients enroll in the long term extension study.\" The Phase 2 trial is designed as a multi-center, randomized, double-blind, placebo-controlled study to investigate the safety, efficacy and pharmacokinetics of REC-994. The primary outcome is specific to safety and tolerability, measured by adverse events. The secondary outcomes center on efficacy, including clinician- and patient-reported outcomes, imaging of CCM lesions (number, size & rate of change), the impact of acute stroke, as well as exploratory biomarkers. About REC-994 REC-994 is an orally bioavailable small molecule superoxide scavenger being developed for the treatment of CCM. In Phase 1 single ascending dose, or SAD, and multiple ascending dose, or MAD, trials in healthy volunteers that Recursion conducted, REC-994 demonstrated tolerability and suitability for chronic dosing. REC-994 has been granted Orphan Drug designation for CCM by the U.S. Food and Drug Administration and the European Commission. About Cerebral Cavernous Malformation CCM is a neurovascular disease caused by inherited or somatic mutations in any of three genes involved in endothelial function: CCM1, CCM2, or CCM3. Approximately 360,000 patients in the United States and EU5 are impacted by symptomatic CCM, where approximately 20% of patients have a familial form of CCM that is inherited in an autosomal dominant pattern, leading to multigenerational disease that is extremely impactful for affected families. Moreover, appr...